UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058988 |
|---|---|
| Receipt number | R000067460 |
| Scientific Title | The association between serum calcium control status and incidence of renal dysfunction in patients with chronic hypoparathyroidism: a retrospective cohort study using medical institution-based data |
| Date of disclosure of the study information | 2025/09/05 |
| Last modified on | 2025/09/04 10:18:06 |
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Basic information
Public title
Database study on the association between serum calcium control status and incidence of renal dysfunction in patients with chronic hypoparathyroidism
Acronym
Database study on the association between serum calcium control status and incidence of renal dysfunction in patients with chronic hypoparathyroidism
Scientific Title
The association between serum calcium control status and incidence of renal dysfunction in patients with chronic hypoparathyroidism: a retrospective cohort study using medical institution-based data
Scientific Title:Acronym
The association between serum calcium control status and incidence of renal dysfunction in patients with chronic hypoparathyroidism: a retrospective cohort study using medical institution-based data
Region
| Japan |
Condition
Condition
Hypoparathyroidism
Classification by specialty
| Endocrinology and Metabolism | Nephrology | Endocrine surgery |
| Pediatrics | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between renal dysfunction and serum calcium control, conventional therapies (active Vitamin D3 and calcium supplements), and other factors in patients with chronic hypoparathyroidism in actual clinical settings using medical institution-based data.
Basic objectives2
Others
Basic objectives -Others
Description of serum calcium control status, incidence of renal dysfunction, etc., and exploratory analysis for factors associated with renal dysfunction risk
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of renal dysfunction, based on status of serum calcium control
Key secondary outcomes
- Incidence of urinary stones (including nephrolithiasis and nephrocalcinosis), based on status of serum calcium control
- Changes in laboratory test values, based on status of serum calcium control
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all the following criteria will be included.
(1) Patients who satisfied any of the hypoparathyroidism criteria for the first time between April 1, 2010 and November 30, 2023
(2) Patients having medical records for no less than 180 days prior to (1)
(3) Patients who received an outpatient prescription for conventional therapy from (1) to between 180 days and 300 days after (1)
(4) Patients with at least one prescription of conventional therapy from (1) to the day before (3)
(5) Patients who had received medical care since (3)
(6) Patients who had serum calcium levels and serum albumin levels, obtained on the same day, from (3) to 90 days before (3)
(7) Patients who had eGFR values obtained from (3) to 90 days before (3)
(8) Patients who had at least one recorded eGFR value of 30mL/min/1.73m^2 or more from 90 days before to 90 days after (1)
Key exclusion criteria
Patients who meet any of the following criteria will be excluded.
(1) Patients who satisfied any one of the hypoparathyroidism criteria from 1 day to 180 days before inclusion criterion (1)
(2) Patients with diagnosis codes for pseudo-hypoparathyroidism from 1 day to 180 days before (3)
(3) Patients with at least one recorded eGFR value less than 15mL/min/1.73m^2 between inclusion criteria (1) to (3)
(4) Patients with a history of end-stage kidney disorders between inclusion criteria (1) to (3)
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Sugiyama |
Organization
Teijin Pharma Limited
Division name
Medical Science Department
Zip code
100-8585
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
TEL
03-3506-4140
tpm-com@umin.ac.jp
Public contact
Name of contact person
| 1st name | Mana |
| Middle name | |
| Last name | Kujirai |
Organization
Teijin Pharma Limited
Division name
Medical Science Department
Zip code
100-8585
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
TEL
03-3506-4140
Homepage URL
tpm-com@umin.ac.jp
Sponsor or person
Institute
Teijin Pharma Limited
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teijin Pharma Limited
Address
2-1, Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
Tel
03-3506-4140
tpm-com@umin.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 31 | Day |
Other
Other related information
This is a database study using an existing database, the MDV database.
Management information
Registered date
| 2025 | Year | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067460
